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Completed

NCT Number: NCT02104466

Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN)

Peripheral neuropathy is a common complication of diabetes, and one of the strongest determinants of reduced health-related quality of life among people with diabetes. Neuropathy frequently presents with painful symptoms, activity limitation, insomnia, fatigue, and depressive symptoms. Anti-convulsants and tricyclic anti-depressants provide at least moderate pain relief for 25-50% of patients with painful diabetic neuropathy (PDN), but often decrease other domains of quality of life through adverse effects, such as dry mouth, dizziness, nausea, drowsiness, and urinary problems. Effective, non-pharmaceutical approaches for PDN are needed, particularly for low income and racial/ethnic minorities who are at highest risk of diabetes and related complications. Acupuncture is a promising treatment for PDN, but evidence is limited. To address the significant public health need related to pain management among underserved people with diabetes, this study proposes an innovative, group-based model of acupuncture for PDN at an urban safety net hospital. Sixty patients who have PDN will be enrolled and randomized to one of three arms: (a) usual care combined with 12 weeks of group acupuncture twice weekly, (b) usual care combined with 12 weeks of group acupuncture once weekly, or (c) usual care alone (20 in each group). The aims of the study are to determine the feasibility of group acupuncture for PDN among underserved patients with diabetes; to evaluate the preliminary treatment effects of group acupuncture on pain, health-related quality of life, depressive symptoms, sleep disturbance, nerve conduction velocity, and protective sensation; and to determine the optimal frequency of acupuncture treatments.

The investigators hypothesize that compared to patients receiving usual care alone, patients who undergo weekly group acupuncture treatments will have:

1. decreased pain intensity 2. improved health-related quality of life 3. improved sural nerve conduction velocity

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Key information

Conditions

Diabetic Peripheral Neuropathy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English, Spanish, or Cantonese speaking
  • Diagnosed with type 2 diabetes mellitus
  • Distal lower limb pain present for at least three months
  • A score of 4 or greater on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) for the pain of diabetic peripheral neuropathy at least four days a week before randomization
  • Pain characterized as burning, shooting, or stabbing in nature
  • Ability to understand study procedures and willingness to comply with them for the entire length of the study
  • A score of less than 8 on the Semmes-Weinstein monofilament test
  • Stable use of pain control medications for PDN in the one month prior to screening (e.g. no change in prescription) or no use of pain control medications for PDN within the past one month

Exclusion criteria

  • Substance abuse (as assessed by the Simple Screening Instrument for Substance Abuse)
  • Unstable medical condition (e.g. severe pulmonary disease, myocardial infarction, severe depressive symptoms)
  • Electrical therapy (e.g. TENS unit) or patch treatment (e.g. lidocaine or capsaicin) for PDN used within the past two weeks
  • Acupuncture, moxibustion, cupping or herbal medicine for PDN used within the past two weeks
  • Pregnancy, planning a pregnancy or breast-feeding
  • Inability or unwillingness to comply with this study protocol, assessed prior to randomization

Treatment and study plan

Acupuncture

Procedure

Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. The initial acupuncture treatment will include a one-on-one diagnostic interview with one of the study acupuncturists for up to 30 minutes, followed by administration of acupuncture needles retained for 20-40 minutes. For subsequent group acupuncture treatments, participants will have a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Eight to twelve needles will be administered in acupuncture points selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.

Primary outcomes

  1. Percentage of recruited participants retained for the 12-week intervention period

    Time frame: 12 weeks

  2. Change from baseline in average weekly pain on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at week 12

    Time frame: Baseline, Weeks 1-12

Secondary outcomes

  1. Pain Qualities Assessment Scale

    Time frame: Baseline, Weeks 1-12, Week 24

  2. Health-related quality of life

    Time frame: Baseline, Week 6, Week 12, Week 18

    The following questionnaires will be used: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy; Diabetes Distress Scale; Brief Pain Inventory Interference Scale; Centers for Disease Control and Prevention Healthy Days Measure

  3. Depressive symptoms using the Patient Health Questionnaire

    Time frame: Baseline, Week 6, Week 12, Week 18

  4. Participant rating of global improvement using the Patient Global Impression of Change scale

    Time frame: Week 12

  5. Patient-centered symptom severity using the Measure Yourself Medical Outcome Profile

    Time frame: Baseline, Week 6, Week 12, Week 18

  6. NIH PROMIS Sleep Disturbance Scale

    Time frame: Baseline, Week 6, Week 12, Week 18

  7. Protective sensation of the feet using a 5.07 Semmes-Weinstein monofilament

    Time frame: Baseline, Week 12, Week 18

  8. Patient satisfaction

    Time frame: Week 12

    At Week 12, an exit interview will be administered to inquire about satisfaction with the acupuncture services and study procedures.

Other outcomes

  1. Use of medications at baseline and throughout 12-week intervention period

    Time frame: Baseline, Week 12

    Data about medication use will be extracted from the participant's medical chart, including type(s) of analgesics, total dose, and the number of agents.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Randomized Controlled Pilot Trial of Adjunct Group Acupuncture vs Usual Care Among Patients With Painful Diabetic Neuropathy

Acronym: GATE-PDN

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 4, 2014
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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